Gemcitabine treatment in pretreated cutaneous T-cell lymphoma: Experience in 44 patients

Purpose: to evaluate the efficacy and toxicity of gemcitabine, a novel pyri midine antimetabolite with a low-toxicity profile and activity in several s olid tumors, in patients with relapsed or refractory cutaneous T-cell lymph omas. Patients and Methods: Between May 1997 and February 1999, 44 previously tre ated patients with mycosis fungoides (MF; n = 30) and peripheral T-cell lym phoma unspecified (PTCLU) with exclusive skin involvement (n = 14) were enr olled onto a two-institution, phase II trial and created with gemcitabine. This drug was given on days 1, 8, and 15 of a 28-day schedule at a dose of 1,200 mg/m(2) intravenously over 30 minutes for a total of three courser. Results: Of the 44 patients, five (11.5%) achieved complete responses (CRs) , 26 (59%) partial responses (PRs), and the remaining 13 showed no benefit from the treatment. Two of the CRs were histologically confirmed. The CR an d PR rates were the same for patients with MF and those with PTCLU, respect ively. No difference in terms of overall response rate was observed between relapsed and refractory patients. The median durations of CR and PR were 1 5 months (range, 6 to 22 months) and 10 months (range, 2 to 15 months), res pectively. Treatment was well tolerated; hematologic toxicity was mild, and no nausea/vomiting or organ toxicity wens recorded. Conclusion: The results of the present phase II study show activity of gemc itabine as a single agent in patients with pretreated cutaneous T-cell lymp homa. Further studies that use gemcitabine alone or in combination with oth er drugs in earlier stages of the disease are needed. J Clin Oncol 18:2603- 2606. (C) 2000 by American Society of Clinical Oncology.